Product Classification

• Device: sterilization wrap containers, trays, cassettes & other accessories
• Regulation Medical Specialty: General Hospital
• Review Panel: Orthopedic
• Product Code: KCT
• Premarket Review: Spinal Devices (DHT6B); Spinal Devices (DHT6B)
• Submission Type: 510(k)
• Regulation Number: 880.6850
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 14-396 ANSI AAMI ST77:2013/(R)2018
  Containment devices for reusable medical device sterilization

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc